Kornimate/medical-research-clean huggingface dataset:
comparison of bone effects with copaxone and interferon in multiple sclerosis

Conditions: Multiple Sclerosis; Low Bone Density

Summary: the purpose of this study is to determine if certain drugs commonly used to treat multiple sclerosis have an effect on bone health.

there will be 60 female patients with ms at university of kansas medical center (kumc). they will be split into two groups: a copaxone group and an interferon (avonex, rebif, or betaseron) group. each group will be composed of 30 women matched for menopausal status. each subject will be given a questionnaire assessing risk factors for low bone density. all patients will have a determination of an expanded disability status scale (edss), height and weight, medical history, and fracture history. all patients will undergo hip and spine dual x-ray absorptiometry (dexa) and will have labs drawn to determine serum 25 hydroxyvitamin d, parathyroid hormone, ionized calcium, estradiol, bone-specific acetyl phosphatase, osteocalcin, and c-peptides.

Eligibility criteria:
inclusion criteria: * female, age \> 18 * able to understand and give informed consent * relapsing remitting multiple sclerosis (rrms) * treatment with interferons or copaxone for at least one year prior to study entry exclusion criteria: * known osteoporosis * history of hypercalcemia * currently pregnant * history of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism * unstable medical condition * ongoing use of bisphosphonates

Keywords: ms (multiple sclerosis)
efficacy and safety of pasireotide administered monthly in patients with cushing's disease

Conditions: Cushing's Disease

Summary: this is a randomized, double-blind, multicenter, phase iii study to evaluate the safety and efficacy of 2 dosing regiments of pasireotide long acting release (lar) in patients with cushing's disease.


Eligibility criteria:
inclusion criteria: * karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs) * for patients on medical treatment for cushing's disease the following washout periods must be completed before screening assessments are performed * inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week * pituitary directed agents: dopamine agonists (bromocriptine, cabergoline) and pparγ agonists (rosiglitazone or pioglitazone): 4 weeks * octreotide lar, lanreotide sr and lanreotide autogel: 14 weeks * octreotide (immediate release formulation): 1 week exclusion criteria: * patients who are considered candidates for surgical treatment at the time of study entry * patients who have received pituitary irradiation within the last ten years prior to visit 1 * patients who have had any previous pasireotide treatment * patients who have been treated with mitotane during the last 6 months prior to visit 1 * diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by hba1c \>8% * patients with risk factors for torsade de pointes, i.e. patients with a baseline qtcf \>470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long qt syndrome, or concomitant medications known to prolong qt interval * female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid

Keywords: som230 cushing's disease mean urinary free cortisol pasireotide pasireotide lar pasireotide long-acting release secondary hypercortisolism secondary hypercorticism itsenko-cushing disease increased secretion of adrenocorticotropic hormone (acth) hyperpituitarism
forxiga hf general drug use-results study

Conditions: Heart Failure

Summary: to capture safety when forxiga is administered to patients with hf in clinical practice after launch.

the purpose of the study is to review the following points during use of forxiga tablets (hereinafter referred to as forxiga) in the real world setting after launch. 1. adrs which are unexpected from the precautions for use 2. understanding of incidence of adrs during use of forxiga in the real world setting 3. factors possibly having an impact on the safety

Eligibility criteria:
inclusion criteria: * patients aged more than 15 years * patients who have been prescribed forxiga for the first time exclusion criteria: * patients with a history of hypersensitivity to any ingredients of this drug. * patients with severe ketosis, diabetic coma or precoma * patients with severe infections, before or after a surgery, or with serious trauma
factors associated with cesarean delivery in women with type 1 diabetes

Conditions: Pregnant Women; Diabetes Type 1; Cesrean Delivery

Summary: introduction : cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. having a prior c-section is the most important risk factor. the aim of this study was to identify risk factor of cesarean in this population. methods: this study is an observational, retrospective and single-center study from the hospital of montpellier. all the pregnancies, planned or not, with subcutaneous insulin infusion or multiple daily injections of insulin, in patients with diabetes type 1 between 2009 and 2015, after 24 weeks of gestation were included. all the data were retrospectively collected by the principal investigator with computer and paper files.


Eligibility criteria:
inclusion criteria: * pregnant women with diabetes type 1 * pregnancy initiated between 2009 and 2015 * pregnancy followed up in the universitary hospital center of montpellier exclusion criteria: * women who deliver in an other center * women with intraperitoneal injections of insulin * twin gestation * termination of pregnancy

Keywords: cesrean delivery risks factors diabetes type 1
compassionate use of dupilumab for adult patients with bullous pemphigoid

Conditions: Bullous Pemphigoid

Summary: the objective of the program is to provide patients with bullous pemphigoid (bp), that participated in the r668-bp-1902 (nct04206553) phase 2/3 study, dupilumab treatment and evaluate the long-term safety of dupilumab.

expanded access requests are only being considered in response to intermediate size patient population applications. availability will depend on location.

Eligibility criteria:
key inclusion criteria: 1. completion of the end of study (eos) visit in the parent dupilumab phase 2/3 study, r668-bp-1902 (nct04206553) key exclusion criteria: 1. patients who, during the parent dupilumab study, r668-bp-1902 (nct04206553), developed a serious adverse event (sae) and/or adverse event (ae) deemed related to program drug and which led to discontinuation of investigational product 2. treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit 3. treatment with bp-directed biologics, as defined in the protocol 4. treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit 5. planned or anticipated use of any prohibited medications or procedures during program treatment 6. severe concomitant illness(es) that, in the treating physician's judgment, would adversely affect the patient's participation in the program note: other protocol defined inclusion/exclusion criteria apply

Keywords: skin diseases autoimmune diseases immune system diseases inflammatory diseases
effect of coenzyme q10 administration on polycystic ovary syndrome

Conditions: Polycystic Ovarian Syndrome (PCOS)

Summary: the goal of this clinical trial is to determine the effects of coenzyme q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. the main questions it aims to answer are: does coenzyme q10 alter oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. participants will take coenzyme q10 200mg, once daily for a period of 3 months. the participants will be reassessed after 12 weeks by measuring malondialdehyde mda, c-reactive protein crp, sex hormone binding globulin shbg.


Eligibility criteria:
inclusion criteria: * married patients that presented with anovulatory infertility due to pcos. * unmarried patients that presented with symptoms due to pcos * all patients should fulfill rotterdam criteria for pcos exclusion criteria: * male factor infertility ( oligospermia or aspermia) * tubal factor infertility (abnormal hysterosalpingography) * diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function * autoimmune and inflammatory disorders * abnormal serum prolactin level * smokers * alcoholic beverage use * use of anti diabetic, anti-obesity drugs, insulin or vitamin and mineral supplements

Keywords: pcos
a study comparing the differences between young and non-young breast cancer

Conditions: Breast Cancer

Summary: to collect data on diagnosis, treatment, survival prognosis, and intrinsic molecular detection of breast cancer in china from january 2000 to december 2024.compare the difference between young and non-young breast cancer.


Eligibility criteria:
inclusion criteria: * during the period from january 2000 to december 2024, the first breast cancer diagnosed and treated in several hospitals in china was in the age range of 18-75 years. exclusion criteria: * breast cancer patients under 18 years of age or over 75 years of age; combined with other malignant tumors; patients with chronic infectious diseases or chronic infectious diseases; patients with severe comorbidities, with serious dysfunction of vital organs (heart, liver, kidney); known history of human immunodeficiency virus; the investigator concluded that patients should not be included in other conditions of this trial.
albumin 4 gr/l vs 8 gr/l in the prevention of post-paracentesis circulatory dysfunction

Conditions: Tense Ascites in Cirrhosis

Summary: the purpose of this study is to determine whether the infusion of albumin 4 gr per liter of ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed in the prevention of post-paracentesis circulatory dysfunction

large-volume paracentesis associated with plasma volume expansion is the first-line treatment of tense ascites in cirrhotic patients. when paracentesis is performed without volume expansion, an high proportion of patients develop a complication named post-paracentesis circulatory dysfunction, which is characterized by a marked activation of the renin-angiotensin-aldosterone system. ppcd has been associated with renal impairment, rapid recurrence of ascites and shorter survival. infusion of albumin is very effective in the prevention of ppcd, but has sever inherent drawbacks: the theoretical possibility of transmission of infectious diseases and the high costs. other synthetic plasma volume expanders have been proposed in the last decades, but they are less effective than albumin when large (\> 5 l) volume paracentesis are performed. albumin is conventionally given in a dosage of 8 gr per liter of ascites removed; however no information has yet been reported on the use of lower dosages of albumin in this context. this would be interesting, because of the obvious advantages in terms of costs reduction. the aim of the present study is to compare the efficacy of the infusion of albumin 4 gr vs 8 gr per liter of ascites removed in the prevention of ppcd.

Eligibility criteria:
inclusion criteria: * cirrhosis and ascites submitted to paracentesis \> 5 liters * age: 18-75 years * informed written consent exclusion criteria: * multinodular hcc (\> 3 nodules) * portal vein thrombosis * ongoing bacterial infection * ongoing or recent (less than one week) bleeding * cardio-pulmonary failure * hepatorenal syndrome type 1 * severe coagulopathy: platelets \< 30.000/mm3 and/or pt \< 30% * ongoing treatment with vasoactive drugs

Keywords: ascites cirrhosis post-paracentesis circulatory dysfunction albumin portal-hypertension
tilting of radioactive plaques after initial accurate placement for treatment of uveal melanoma

Conditions: Uveal Melanoma

Summary: plaque radiotherapy is a common treatment for uveal melanoma. however, local failure has been reported in up to 20% of patients. we use intraoperative ultrasonography at plaque insertion and removal to evaluate plaque movement as a potential factor in local failure.

episcleral plaque radiotherapy is a common treatment for uveal melanoma and results in local tumor control in most cases. however, local failure has been reported in a substantial proportion of patients. since local failure greatly increases the risk of metastatic death, identifying and correcting the causes of local treatment failure are of paramount importance. poor plaque localization is an important contributing factor to local failure. with the aid of intraoperative ultrasonography, most malpositioned plaques can be identified and readjusted at the time of plaque insertion. however, little is known about plaque movement during the 4-5 days of brachytherapy, which could also contribute to local failure. to address this question, we perform intraoperative b-scan ultrasonography at the time of iodine-125 radioactive plaque insertion and removal in uveal melanoma patients.

Eligibility criteria:
inclusion criteria: * all patients with uveal melanoma treated with brachytherapy exclusion criteria: * ciliary melanoma

Keywords: melanoma brachytherapy ultrasonography
comparision of m-tapa versus tapb after laparoscopic cholecystectomy

Conditions: Postoperative Pain, Acute

Summary: this randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (m-tapa) in patients undergoing laparoscopic cholecystectomy. the investigators hypothesized that the us-guided m-tapa would be more effective in postoperative pain control than the us-guided subcostal transversus abdominis plane block (tapb).

patients (age\>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral us-guided m-tapa (n=30) or bilateral subcostal tapb (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. the blinded investigator evaluates each patient's parameters (numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. the primary outcome is pain severity evaluated by a nrs at 12hours postoperatively.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective laparoscopic cholecystectomy * american society of anesthesiologists (asa) physical classification i-ii exclusion criteria: * american society of anesthesiologists (asa) physical classification iii or more * chronic pain, chronic analgesic or antidepressant or anticonvulsant use * allergies to anesthetic or analgesic medications used in the protocol * single port laparoscopic cholecystectomy * patients with infection at the abdominal wall * medical or psychological disease that can affect the treatment response * do not understand our study

Keywords: cholecystectomy thoracoabdominal nerves block transversus abdominis plane block interfascial plane block regional analgesia
mri and orbital tumours (medort)

Conditions: Orbital Tumor; Orbital Pseudotumor

Summary: orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. these masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation. pathology is of considerable importance for the diagnosis and the treatment of those masses. however, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers. the identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients. the mri assessment performed routinely in a patient with an orbital mass includes morphological sequences t1, t2 fat suppression, t1 injected fat suppression, diffusion. this exploration requires, regardless of the performed research, a contrast agent injection (0.1 mg / kg weight of gadobutrol®). in this research protocol, during the injection of the contrast agent performed during the mri assessment performed routinely, a dce perfusion sequence, which consists of a repeated acquisition at short intervals of a volume gradient echo t1, will be added. this acquisition will be preceded by two short series for calibration. the post treatment will include parametric permeability cards (ktrans) and plasmatic volume (vp), evaluating one or more regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being the reference. it will also be added a magnetic susceptibility epi sequence type. all the qualitative parameters (t1, t2, t1 injected, distribution, low signal intensity in susceptibility) and quantitative (ktrans, vp, relative intensity enhancement, apparent diffusion coefficient) parameters will be collected. the result of the pathological exam of the biopsy or of the surgical specimen, which is the gold-standard, will be collected.


Eligibility criteria:
inclusion criteria: * patient aged over 18 years, with an orbital mass for which a biopsy or a resection is planned, coming for an mri, before any surgical treatment exclusion criteria: * absolute or relative contra-indication to mri or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women) * patient under guardianship * patient not willing to participate. * lack of affiliation to social security or medical state aid (ame) or universal health coverage (cmu) * motion artifact on the sequences, not corrected by the repeat sequences * metal artifact prohibiting the analysis of the region of interest * biopsy or resection not performed, particularly if the orbital mass is due to an infection * mri findings allowing a diagnosis without the need for pathology
mfolfirinox as first-line chemotherapy in treating chinese patients with metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: this phase ⅱ study was designed to evaluate the efficacy and safety of mfolfirinox as first-line treatment for metastatic pancreatic cancer in china.

although folfirinox regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in china. since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase ⅱ study to evaluate the the efficacy and safety of mfolfirinox as first-line treatment for metastatic pancreatic cancer in china.

Eligibility criteria:
inclusion criteria: * patients have provided a signed informed consent form * ecog performance status of 0-1 * bmi ≥ 18.5 * age: 18-65 years old * histologically confirmed diagnosis of metastatic pancreatic cancer * no prior palliative chemotherapy * measurable disease in at least 1 diameter by ct scan or mri as per recist 1.1 criteria * life expectancy ≥ 3 months * patient has adequate bone marrow and organ function * absolute neutrophil count (anc) ≥ 2.0 x 109/l * platelets ≥ 90 x 109/l * hemoglobin ≥ 90 g/l * patient has adequate liver function * ast and alt not more than 2.5 times uln (not more than 5.0 times uln if there is liver metastasis) * serum bilirubin ≤ 1.2 x uln * creatinine ≤ 1.25 times uln * good compliance exclusion criteria: * pregnant or lactating women * brain metastasis or only with bone metastasis. * patients with severe gastrointestinal hemorrhage which need frequent blood transfusions. * refuse to take appropriate contraceptive measures (including male patients). * allergic to oxaliplatin, irinotecan, leucovorin or 5-fluorouracil. * severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases. * patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ). * psychiatric illness that would prevent the patient from giving informed consent. * patient is concurrently using other antineoplastic agent * patient has used investigational antineoplastic agent within 4 weeks prior to entry. * known hiv-positivity. * no history of chronic diarrhea, nausea or vomit. * no ≥ grade 2 sensory peripheral neuropathy. * a history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina. * infectious disease or inflammation with body temperature ≥ 38 ℃.
copd research registry

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the copd research registry is a confidential database of individuals diagnosed with copd or at risk of developing copd. the registry was established in 2007 by the copd foundation with the purpose of providing a mechanism for researchers to boost enrollment in clinical trials and other research studies. the copd foundation is working with national jewish health in denver, colorado to serve as the registry's data coordinating center and to ensure strictest confidentiality of participant information.


Eligibility criteria:
inclusion criteria: -individuals over the age of 18 who have copd or may be considered to be at increased risk for development of copd. exclusion criteria: -individuals under the age of 18